The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe® Mapping and Ablation System for treating patients with atrial fibrillation.
Upon successful enrolment, subjects will be scheduled for mapping and radiofrequency (RF) ablation. Cardiac CT imaging, echocardiography and baseline 12-lead ECG will be performed pre-procedure for screening and health assessment. During the procedure the Globe catheter will be delivered via standard femoral vein access and transseptal puncture. Anatomical and electrophysiological mapping of the left atrium (LA) will be followed by RF ablation to achieve pulmonary vein isolation (PVI). Additional lesions will be created as deemed appropriate by the investigator. Intracardiac electrogram mapping will be used to confirm PVI during the procedure. Echocardiography will be performed at discharge to assess cardiac function. Electrocardiograms by 12-lead ECG and 7-day Holter monitoring will be recorded at discharge, and 3, 6 and 12 months after treatment. Follow-up assessments will be performed at discharge, 7 days, and 1, 3, 6 and 12 months after treatment, to track freedom from documented AF and adverse events. Subject-reported AF symptomology and quality of life will also be assessed during follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
During the procedure the Globe catheter will be delivered via standard femoral vein access and transseptal puncture. Anatomical and electrophysiological mapping of the LA will be followed by pulmonary vein isolation (PVI) by RF ablation. Additional lesions will be created as deemed appropriate by the investigator.
Herzzentrum Leipzig GmbH
Leipzig, Saxony, Germany
Klinik Hirslanden
Zurich, Switzerland
Rate of subjects presenting pre-defined serious adverse events occurring within 7 days of the procedure
Rate of subjects presenting with one or more of the following serious adverse events occurring within 7-days of the procedure: * Transient ischemic attack * Cerebrovascular accident * Major bleeding * Cardiac tamponade * Pulmonary vein stenosis * Pericarditis * Myocardial infarction * Diaphragmatic paralysis * Atrio-esophageal fistula * Valvular damage * Phrenic nerve palsy * Intra-procedural device complication requiring open chest or heart surgery * Death
Time frame: 7 days
Subjects presenting with adverse events
* Subjects presenting with primary serious adverse events up to 1 year * Subjects presenting with adverse events or serious adverse events up to 1 year
Time frame: Up to 1 year
Acute procedural success
Acute device performance in achieving entrance block of the pulmonary veins
Time frame: Intra-procedurally
Rate of freedom from documented atrial fibrillation
Rate of freedom from electrocardiographically documented atrial fibrillation between 3 months and 1 year post-ablation
Time frame: Between 3 months and 1 year
Change in Quality of life and AF symptom frequency and severity scores
Change of quality of life (SF-36) and AF symptom frequency and severity (Bubien et al 1993) questionnaire scores from baseline to 1 year after ablation
Time frame: Up to 1 year
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